NCT04537468已完成不适用
Development of a Method to Measure mRNA Levels From the Skin of Patients With Psoriasis and Patients With Atopic Dermatitis Using Tape Strippings
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Expression of skin biomarkers
研究概览
简要总结
The purpose of this study was to develop a non-invasive method to measure mRNA levels using tape stripping on the skin of patients with psoriasis and patients with atopic dermatitis.
详细描述
Three sequential groups of subjects were recruited in this study for: 1) skin squame collection; 2) tape strip collection; and 3) tape strip and skin biopsy collection in the aim of identifying the most optimal method for measuring the mRNA levels of skin biomarkers in tape strip samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject, male or female, aged 18 years or older at the time of consent.
- •Female subjects of childbearing potential had a negative urine pregnancy test at the screening visit.
- •Subjects had to be able and willing to provide written informed consent and comply with the requirements of the study protocol. Consent was obtained prior to any study-related procedures.
- •*Special inclusion criteria for volunteers with atopic dermatitis or psoriasis:
- •Patient had a history of atopic dermatitis or psoriasis.
- •Patient with psoriasis had a Physician's Global Assessment (PGA) score of ≥2 at Day
- •Patients with atopic dermatitis had an Investigator's Global Assessment (IGA) score of ≥2 at Day 0.
排除标准
- •Female subject was pregnant or breastfeeding.
- •Subject was participating in a clinical trial with an experimental drug or device or had participated in a clinical trial with an experimental drug or device within the last 4 weeks of the collection day (Day 0).
- •Subject was known to have hepatitis B or hepatitis C viral infection.
- •Subject was known to have immune deficiency or was immunocompromised.
- •Subject had used systemic medication, medical devices, UVB or PUVA therapy or natural health products to treat atopic dermatitis or psoriasis on the areas to be biopsied or tape stripped within 4 weeks of the collection day (Day 0).
- •Subject had used oral, intravenous steroids, or immunosuppressive medication within 4 weeks of the collection day (Day 0). Subject had used intramuscular or intra-lesional or intra-articular steroids or immunosuppressive medication on the areas to be biopsied or tape stripped within 4 weeks of the collection day (Day 0).
- •Subject had used a biologic within 12 weeks or 5 half-lives of the collection day (Day 0), whichever was longer.
- •Subject had used topical medication, natural health products or medical devices to treat atopic dermatitis or psoriasis on the areas to be tape stripped or biopsied within 2 weeks of the collection day (Day 0).
- •*Only for subjects who underwent skin biopsy:
- •Subject had a known hypersensitivity/allergy to lidocaine.
- •Subject had a history of hypertrophic scarring or keloid formation in scars or suture sites.
- •Subject was taking anti-coagulant medication (e.g. heparin, low molecular weight [LMW]-heparin, warfarin, anti-platelets [nonsteroidal anti-inflammatory drugs (NSAIDs) and low-dose aspirin (equal or lower than 81 mg) were not considered anti-platelets]) or had a contraindication to skin biopsies.
结局指标
主要结局
Expression of skin biomarkers
时间窗: Day 0
Gene expression of epidermal cytokines and chemokines.
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
尚未招募
不适用
Patients with SARSCOV-2 with its mRNA levels of Blimp1 alpha and betaCTRI/2020/12/029868SN Medical college
已完成
不适用
Measurement of Frataxin mRNA in BiofluidsFriedreich AtaxiaNCT06496451University of Florida10
已完成
不适用
Pilot Tape Harvesting StudyHealthyAtopic DermatitisSubacute Cutaneous Lupus ErythematosusDiscoid Lupus ErythematosusNCT02125695Biogen37
Unknown
不适用
Non-invasive Test to Detect Intra-amniotic Infection in Women With Preterm Labor and Intact Amniotic MembranesIntra-amniotic InfectionNCT00700219ProteoGenix, Inc.900
招募中
不适用
An In-situ Detection for MicroRNABreast CancerNCT06529614Tongji Hospital100